Diabetes Mellitus is a disease or disorder of the body's metabolic functions, characterized by abnormally high levels of blood glucose and inadequate levels of insulin. In 2012, 29.1 million Americans, or 9.3 percent of the population had diabetes, up from 25.8 million, or 8.3 percent, in 2010. New cases diagnosed in 2012 were 1.7 million, and in 2010 it was 1.9 million. Diabetes Mellitus Type 1, formerly known as juvenile diabetes, is usually diagnosed in children and young adults, and only 5 percent of people with diabetes have this form of the disease.
In Type 1 diabetes, the body does not produce insulin, a hormone necessary to convert sugar, starches, and other food into energy needed for daily life. Diabetes Mellitus Type 2 is far more common, and affects 90-95 percent of all diabetics in the United States of America. In Type 2 diabetes, the body does not use insulin properly, which is called insulin resistance. At first, the pancreas makes extra insulin to make up for it, but, over time the pancreas is not able to keep up and can't make enough insulin to keep blood glucose at normal levels. The long-term adverse effects include blindness, loss of kidney function, nerve damage, loss of sensation, and poor circulation in the periphery, and amputation of the extremities. As of Mar. 6, 2013, the total cost of diagnosed diabetes in the United States in 2012 was $245 billion dollars.
In the treatment of Diabetes Mellitus, many varieties of insulin formulations have been suggested and used, such as regular insulin, isophane insulin (designated NPH®), insulin zinc suspensions (such as SEMILENTE®, LENTE®, and ULTRALENTE®), and biphasic isophane insulin. As diabetic patients are treated with insulin for several decades, there is a major need for safe and life quality improving insulin formulations. Some of the commercially available insulin formulations are characterized by a fast onset of action and other formulations have a relatively slow onset but show a more or less prolonged action. Fast-acting insulin formulations are usually solutions of insulin, while retarded acting insulin formulations can have suspensions containing insulin in crystalline and/or amorphous form precipitated by addition of zinc salts alone, by addition of protamine, or by a combination of both.
In addition, some patients are using formulations having both a fast onset of action and a more prolonged action. Such a formulation can be an insulin solution, wherein protamine insulin crystals are suspended. Some patients do prepare the final formulation themselves by mixing a fast acting insulin solution with a protracted acting insulin suspension formulation in the ratio desired by the patient in question.
Glucose control is typically measured by a blood test, which determines the level of hemoglobin A1c, which has been the desired result of insulin therapy in diabetic patients for many years. However, it is clear that tight circulating glucose control was insufficient in 25 percent or more of the study participants to protect them from the onset or progression of diabetic retinopathy, nephropathy, or neuropathy. One method of glucose control is Pulsed Insulin Therapy.
The core concept of Pulsed Insulin Therapy has been known for at least 20 years, by various names including Pulsatile Intravenous Insulin Therapy (PIVIT), Chronic Intermittent Intravenous Insulin Therapy (CIIIT), Metabolic Activation Therapy (MAT), and Hepatic Activation. In such therapies a patient's blood glucose is raised and lowered by about 50 mg/dL to 75 mg/dL over a period of several hours by alternating between doses of insulin and sugars or high carbohydrates foods. Although the mechanisms of action have not been clearly explained, it is apparent from the clinical results that the technique has usefulness in treating diabetic implications, including blindness and other ocular manifestations, nerve disease, cardiovascular disease, diabetic nephropathy, and poor wound healing.
Given the long history of these procedures, one would have expected that the treatment parameters would have been optimized long ago to produce the most favorable results. It turns out, however, that the known treatment parameters are insufficient in that regard.
A need exists for a kit that improves impaired hepatic glucose processing in subjects and produce superior results to those previously obtainable.
The present embodiments meet these needs.
The present embodiments are detailed below with reference to the listed Figures.